Category: Uncategorized

Good read from Stephanie Christopher from MDIC – what are the benefits of proactively investing in quality?  https://www.greenlight.guru/blog/proactive-quality-systems

George says, “I have long enjoyed the Global Medical Device podcast series by Greenlight Guru and its host Jon Speer.  I was honored to be a guest on it this past week to discuss the Medical Device Discovery Appraisal Program (#MDDAP) and how MDIC, CDRH at the FDA, the CMMI Institute and participating medical device manufacturers are a part of this Case for Quality initiative.  Give it a listen, let me know your feedback and contact […]

On January 7, CDRH released its latest update regarding their direction for the Digital Health Precertification program.  https://www.raps.org/news-and-articles/news-articles/2019/1/fda-to-test-precert-de-novo-requests-under-pilot The update is significant in that it provides several shifts not previously documented – including leveraging the De Novo approach for SaMD products in the pilot.  Additional comments regarding interpretation on this announcement is at:  https://www.linkedin.com/feed/update/urn:li:activity:6488161308070985728

Looking forward to digging into reading the @greenlightguru overview on the Case for Quality: https://www.greenlight.guru/blog/fda-case-for-quality-2018-comprehensive-review

https://www.youtube.com/watch?v=9u7WSidbSRU  The Q4 webinar on the Case for Quality Medical Device Discovery Appraisal Program #MDDAP is posted.  In addition to giving an program status update, this one covers how Edwards Life Sciences leveraged their CMMI discovery appraisal as part of their improvement efforts and what regulatory benefits they have received.  Contact any of us at Two Harbors with any questions.

Overview of the MDDAP:  https://cmmiinstitute.com/resource-files/public/medical-device-discovery-appraisal-program-program

There is a public view of the capability areas, practice areas and practices as defined in 2.0 version of the CMMI model as of 04DEC2019.  You can get that here.  https://cmmiinstitute.com/resource-files/public/v2-0-materials/cmmi-v2-0-quick-reference-guide 

Great to hear the perspective from Francisco Vicenty at FDA CDRH on how the Medical Device Discovery Appraisal Program (#MDDAP) is progressing. https://www.greenlight.guru/webinar/fda-case-for-quality-3-success?submissionGuid=06c12318-ecde-48bd-aa32-5a9dc31d67f6

Below are two links to two articles regarding the Medical Device Discovery Appraisal Program (MDDAP) from the on-line publication, MedTech Insight.   These articles are part of a series that MTI has been doing on the program.  These articles specifically get into appraiser qualifications and their insights on this program and the possibility of FDA staff being a part of appraisal teams. https://medtech.pharmaintelligence.informa.com/MT122521/Assessing-A-DeviceMakers-Manufacturing-Capability-Is-Serious-Business-Longtime-CMMI-Appraisers-Give https://medtech.pharmaintelligence.informa.com/MT123294/FDA-Staffers-Device-Firm-Employees-Are-Training-As-Appraisal-Team-Members-For-CMMI-Maturity-Model-Pi

Latest podcast from MedTech Insight regarding #MDDAP and lead CMMI appraiser credentials. https://overcast.fm/+DjJgAU44Y